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Trump wants the FDA to move faster. His actions are having the opposite effect.

“It doesn’t help if there’s chaos, demoralization, and demonization of the agency.”

“Instead of it being 9,000 pages, it’ll be 100 pages,” Trump told a group of pharmaceutical company executives, seemingly in reference to FDA’s guidance and rules.
PM Images/Getty

A presidential transition is an inherently uncertain time to be a federal employee. New leaders must be appointed. Potential budget and staff cuts loom menacingly. There’s a lot of flux.

But it’s increasingly clear that President Donald Trump’s takeover of the federal government is smashing the norms of transition right and left.

Look no further than what’s happening at the Food and Drug Administration. The agency has become the perfect encapsulation of a transition gone awry.

The confusion now engulfing the FDA can be traced back to the end of January, when President Trump instituted a hiring freeze for the federal government (a change that’s typical of new presidents). Days later, in a more disruptive move, he issued an executive order requiring two regulations to be cut each time a new one is introduced. Both of these orders came with sparse details on how, exactly, they’d be implemented.

Vox reached out to the FDA as well as the Trump team for comment, which deferred to the OMB, and the OMB to HHS. Each agency said they couldn’t clarify anything at this time.

There are also questions about who will become the FDA’s commissioner, whether its thousands of vacancies will be filled, and what the Trump administration’s calls to weaken it mean. The FDA, which makes sure our food and drugs are safe, has many, many regulations — and Trump has vowed to cut 75 to 80 percent of them. “Instead of it being 9,000 pages, it’ll be 100 pages,” Trump told a group of pharmaceutical company executives, presumably in reference to FDA’s guidance and rules.

Former FDA officials, health industry insiders, and experts who study governance and bureaucracies said this has led to an unprecedented degree of uncertainty — which is being felt at federal agencies across Washington. At a time when Trump wants to streamline the government, and speed up regulation, he’s instead bogging it down.

“There’s uncertainty about who the commissioner [at FDA] is. There’s uncertainty about the hiring freeze. There’s uncertainty about the impact of the new regulations policy,” said Josh Sharfstein, an associate dean at the Johns Hopkins School of Public Health and former deputy commissioner of the FDA.

“Having uncertainty on three fronts at once is especially difficult,” and, he added, can be distracting for bureaucrats. “People spend time worrying instead of doing their work, they spend time planning for different contingencies that may never happen.”

The hiring freeze will slow down Trump’s promise to speed up drug administration

Trump and his advisers have made it clear that they want to see big reforms at the nation’s food and drug regulator. They’ve suggested that the FDA gets in the way of drug innovation by making it too difficult for new medicines to get to the market, and they’ve called for deregulation to spur drug approvals and innovation.

But that’s pretty hard to do when you have a hiring freeze. “The only credible way to speed up the review process is to add additional personnel,” said David Kessler, a former FDA head. “If you’re serious about reducing drug review times, you are going to make sure the agency can hire the people.” Instead, limiting the ability to add staff or whittling down staff may have the opposite of the desired effect.

“The agency is made up of medical and scientific professionals who do their jobs,” Kessler said. “It doesn’t help if there’s chaos, demoralization, and demonization of the agency.”

Elaine Kamarck, the founding director of the Brookings Center for Effective Public Management, isn’t convinced the Trump administration will actually cut down on bureaucracy. “Republicans always come in saying they’re going to cut the size of government but the only administration in modern times to reduce size of government was the Clinton administration.”

Clinton reduced the number of federal employees by some 300,000, creating the smallest government since John F. Kennedy was president. They did that through a months-long regulatory review process.

“Newt Gingrich failed [to cut government] in 1994. Regan failed in the ’80s. Bush failed in the 2000s. The reason they fail is not that it can’t be done — but it has to be done with a scalpel and not an axe, and [Republicans] tend to want to use an axe.”

It’s not clear there’s a real plan for the FDA

There are a few things that need to happen to bring some order to the FDA. Tom Price, Trump’s nominee for secretary of Health Human Services, just got confirmed — after hearings that were also beset by confusion over concerns about conflicts of interest and potential insider trading.

Now that he’s in place, the pick for FDA head should soon be named. Peter Thiel, the billionaire founder of PayPal, has been helping the president shape the process behind the scenes and vet a pool of candidates to lead the agency. Some of the potential choices — including Silicon Valley’s Jim O’Neill and Balaji Srinivasan — would be massive departures from tradition. They don’t have medical degrees, and they’ve called for major overhauls, arguing FDA should dump its requirement that drugs be proven effective, and that we’d be better off if the agency operated more like a “Yelp for drugs.”

Researchers who study the FDA point out that it’s already the fastest drug regulatory agency in the world, and that removing the efficacy requirement could be dangerous to public health.

Even members of the drug industry are nervous about deregulating the agency. “If you ask anyone in the industry, they will tell you they want a well-staffed FDA — adequate in numbers, and high quality people,” said biotech entrepreneur Michael Gilman. “You don’t want an institution where all the good people, all the quality scientists, are demoralized and leaving.”

For now, confusion remains. This week, Rep. Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) wrote a letter to the OMB, asking them to clarify whether the hiring freeze applies to the FDA. They were concerned about what the changes will mean for the bipartisan 21st Century Cures Act, one of the last bills signed by President Obama, which also promises to speed up drug innovation and would require hiring more people at FDA and creating new regulations.

The clinical trial industry is also flummoxed. Doug Peddicord is executive director of the Association of Clinical Research Organizations (ACRO), whose member companies run half the clinical trials in the world. “I think the combination of the hiring freeze, and the lack of an FDA commissioner is making the current transition rather more challenging than earlier changes of administrations,” Peddicord said.

This industry and the drugmakers are powerful lobbies, and their words will carry weight with the administration. (Trump has appointed a former drug lobbyist to head the FDA “beachhead” team — appointees who will serve for the interim.) But that raises another fundamental question: Even if the administration wants to smooth things over with the industry and clarify what changes are in store at FDA, that would require a plan. And it’s not clear they have one.

“What makes this more extreme is that you don’t have a president who came in with pages and pages of policy [details] about what he intended to do,” said Kamarck.

Instead, this was a campaign run on slogans and tweets, she added. “Usually those slogans are backed up by policy papers that give bureaucrats a sense of where the administration wants to go.” Not so this time.

But maybe that’s the point. “Republicans have a strategy,” said Kamarck, “and that strategy is called they don’t like the government, they think it’s too big, and they do things to make it not work right. When it doesn’t work right — it’s a self-fulfilling prophesy.”

Correction: An earlier version of this story misstated the Clinton administration’s cuts to the federal government.

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